HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies

Tracking Information
First Submitted Date ICMJE	June 18, 2011
First Posted Date ICMJE	June 21, 2011
Last Update Posted Date	May 14, 2015
Study Start Date ICMJE	May 2011
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 20, 2011)	Proportion of patients offered an HIV test who accept [ Time Frame: Monthly ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01377857 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 20, 2011)	Proportion testing HIV positive of those tested [ Time Frame: Monthly ]; Proportion testing HIV positive among those offered a test [ Time Frame: Monthly ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies
Official Title ICMJE	HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies
Brief Summary	Over twenty percent of HIV-positive persons in the United States are unaware of their infection, leading the Institute of Medicine to recently urge further work to compare the effectiveness of HIV screening strategies. This study will use a randomized trial to compare several variants of emergency-room-based HIV-testing policies in order to determine how HIV test acceptance rates can be increased. The testing policies will be designed using principles from behavioral economics, varying the choice architecture and offering small monetary incentives. This will be the first study to measure differences in take-up rates across a variety of promising but largely untested approaches within a unified randomized trial. Three defaults will be tested: traditional opt-in (test only those patients who request testing), opt-out (routinely testing unless patients decline), and active-choice testing (patients are required to state whether they want to be tested). The study will also be the first to test the effect of small monetary incentives ($1, $5, $10) on test take-up. An additional novel study contribution will be to test the hypothesis that compliance with large requests (accept an HIV test) increases after making a small request or pre-commitment - this "foot in the door" technique has not been previously studied in this setting. The factorial design will permit a direct comparison of all interventions, as well as interactions. The study will contribute a nuanced empirical understanding of how testing protocols from behavioral economics theory affect the effectiveness and efficiency of screening programs in an actual scaled- up setting (San Francisco General Hospital). This will assist in implementing and assessing recent CDC guidelines on HIV screening, while also more generally advancing scientific knowledge related to applying behavioral economics in comparative effectiveness research.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Screening
Condition ICMJE	HIV
Intervention ICMJE	Behavioral: Monetary Incentive $1, $5, or $10 incentive; Behavioral: Questionnaire Timing Timing of the questionnaire--either before or after testing is offered.; Behavioral: HIV Test Offering HIV Test will be offered as opt-in, opt-out, or active choice.
Study Arms	Experimental: Opt-In Opt-in refers to a default of no test - patients must ask for the test in order to receive it. Patients are informed of the availability of rapid testing. They are tested only if they request the test. Intervention: Behavioral: HIV Test Offering; Experimental: Opt-Out Opt-out has a default to test - patients are informed that they will receive a rapid HIV screening test unless they decline it. Patients will be tested unless they decline. Intervention: Behavioral: HIV Test Offering; Experimental: Active Choice In the active choice treatment, there is no default; patients must actively accept or actively decline the test. Intervention: Behavioral: HIV Test Offering; Experimental: $1 Incentive When offering the HIV test, study staff will inform subjects that the ED is offering cash incentives to promote HIV testing (and that the test is also free), and will inform them of that day's value. Intervention: Behavioral: Monetary Incentive; Experimental: $5 Incentive When offering the HIV test, study staff will inform subjects that the ED is offering cash incentives to promote HIV testing (and that the test is also free), and will inform them of that day's value. Intervention: Behavioral: Monetary Incentive; Experimental: $10 Incentive When offering the HIV test, study staff will inform subjects that the ED is offering cash incentives to promote HIV testing (and that the test is also free), and will inform them of that day's value. Intervention: Behavioral: Monetary Incentive; Experimental: Early Questionnaire At a time that does not interfere with patients' medical care, patients will be approached by a member of the research team to consent to and complete a short (3 minutes) questionnaire. The questionnaire is designed to elicit two things: subjective risk of infection (e.g., What are the chances you have HIV? [Not possible, Unlikely, Possible, Likely, Certain]) and objective risk of infection (e.g., In the past year, have you given anyone drugs or money for sex?). The questionnaire will be administered as one of two timing treatments - a) at the beginning of care, before the patient is offered an HIV test (Early questionnaire) or b) after the patient has been offered an HIV test (Late questionnaire). Intervention: Behavioral: Questionnaire Timing; Experimental: Late Questionnaire At a time that does not interfere with patients' medical care, patients will be approached by a member of the research team to consent to and complete a short (3 minutes) questionnaire. The questionnaire is designed to elicit two things: subjective risk of infection (e.g., What are the chances you have HIV? [Not possible, Unlikely, Possible, Likely, Certain]) and objective risk of infection (e.g., In the past year, have you given anyone drugs or money for sex?). The questionnaire will be administered as one of two timing treatments - a) at the beginning of care, before the patient is offered an HIV test (Early questionnaire) or b) after the patient has been offered an HIV test (Late questionnaire). Intervention: Behavioral: Questionnaire Timing; Experimental: FITD Questionnaire There will be two versions of the early questionnaire: one standard Early questionnaire, and one with an additional question: "If you were offered an HIV test as part of your routine health care at no cost, would you get tested?" The two questionnaires will be otherwise identical. Intervention: Behavioral: Questionnaire Timing; Experimental: Free When offering the HIV test, study staff will inform subjects that the ED is offering HIV testing (and that the test is also free); no monetary incentive will be offered. Intervention: Behavioral: Monetary Incentive
Publications *	Montoy JC, Dow WH, Kaplan BC. Patient choice in opt-in, active choice, and opt-out HIV screening: randomized clinical trial. BMJ. 2016 Jan 19;532:h6895. doi: 10.1136/bmj.h6895.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 13, 2015)	8572
Original Estimated Enrollment ICMJE; (submitted: June 20, 2011)	8000
Actual Study Completion Date	December 2013
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Patients aged 13 - 64 years who are awake, alert, not intoxicated, and understand the premise of the test will be offered the test and questionnaire according to their treatment group. Exclusion Criteria: Patients who have altered levels of consciousness, are critically ill (e.g., serious trauma), are known to have preexisting HIV diagnosis, or who have been tested for HIV in the past 3 months will be excluded from the study.; Pregnant patients will be excluded due to alternative guidelines for incorporating opt-out testing during prenatal care.; Any patients who are in police custody will also be excluded due to their lack of control over study participation decisions and ethical concerns over possible coercion.
Sex/Gender	Sexes Eligible for Study: All
Ages	13 Years to 64 Years (Child, Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01377857
Other Study ID Numbers ICMJE	10562983; 1RC4AG039078-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University of California, San Francisco
Study Sponsor ICMJE	University of California, San Francisco
Collaborators ICMJE	National Institutes of Health (NIH); National Institute on Aging (NIA)
Investigators ICMJE	Principal Investigator: Beth Kaplan, MD University of California, San Francisco Principal Investigator: William H Dow, PhD University of California, Berkeley
PRS Account	University of California, San Francisco
Verification Date	May 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP